FDA Registration for OTC Antibiotic Products

OTC topical antibiotic drug products containing bacitracin, neomycin sulfate, or polymyxin B sulfate are regulated as OTC Monograph drugs by FDA — requiring establishment registration and drug listing.

OTC MonographDrug Facts Labeling21 CFR Part 207Since 2009

FDA Requirements for OTC Antibiotic Drug Products

Topical OTC antibiotic drug products are regulated under FDA’s OTC Monograph system. Common OTC antibiotic active ingredients include bacitracin, neomycin sulfate, and polymyxin B sulfate.

FDA Drug Establishment Registration
NDC Labeler Code
Drug Listing with Drug Facts labeling
Annual renewal October 1–December 31

Over-the-counter (OTC) first aid antibiotic products are regulated by the FDA through a monograph. This ensures they meet specific safety and effectiveness standards. These topical medications help prevent infection in minor cuts, scrapes, and burns.

Active Ingredients	OTC Monograph Number
(a) Bacitracin ointment containing, in each gram, 500 units of bacitracin in a suitable ointment base	M004.10 (Part 333)
(b) Bacitracin zinc ointment containing, in each gram, 500 units of bacitracin zinc in a suitable ointment base	M004.10 (Part 333)
(c) Chlortetracycline hydrochloride ointment containing, in each gram, 30 milligrams of chlortetracycline hydrochloride in a suitable ointment base	M004.10 (Part 333)
(d) Neomycin sulfate ointment containing, in each gram, 3.5 milligrams of neomycin in a suitable water soluble or oleaginous ointment base	M004.10 (Part 333)
(e) Neomycin sulfate cream containing, in each gram, 3.5 milligrams of neomycin in a suitable cream base	M004.10 (Part 333)
(f) Tetracycline hydrochloride ointment containing, in each gram, 30 milligrams of tetracycline hydrochloride in a suitable ointment base	M004.10 (Part 333)

These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.

OTC Antibiotic Products — FAQs

Common questions about FDA registration requirements for otc antibiotic products.

Are OTC antibiotic products regulated differently from prescription antibiotics?

Yes. OTC topical antibiotics (bacitracin, neomycin) are regulated under the OTC Monograph system. Prescription-only antibiotics require NDA or ANDA approval.

Do I need FDA registration to sell first-aid antibiotic ointments?

Yes. Manufacturers of OTC antibiotic products must register with FDA and list each product.